Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology
2 other identifiers
interventional
342
6 countries
49
Brief Summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2014
Typical duration for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2018
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedAugust 28, 2019
July 1, 2019
3.6 years
October 14, 2014
May 1, 2019
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Approximately 43 months post study start
Secondary Outcomes (2)
Overall Survival of All Randomized Participants
Approximately 43 months post study start
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
Approximately 43 months post study start
Study Arms (2)
Arm 1: Carboplatin + Paclitaxel + Ipilimumab
EXPERIMENTALPaclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 2: Carboplatin + Paclitaxel + Placebo
EXPERIMENTALCarboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Interventions
0.9% sodium chloride injection, USP, or 5% dextrose injection
Eligibility Criteria
You may qualify if:
- Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
- Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
- At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
You may not qualify if:
- Brain metastases
- Malignant pleural effusion that is recurrent
- Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Local Institution
Beijing, Beijing Municipality, 100032, China
Local Institution
Beijing, Beijing Municipality, 100042, China
Local Institution
Chongqing, Chongqing Municipality, 400042, China
Local Institution
Fuzhou, Fujian, 350025, China
Local Institution
Guangzhou, Guangdong, 510060, China
Local Institution
Guangzhou, Guangdong, 510080, China
Local Institution
Guangzhou, Guangdong, 510120, China
Local Institution
Shantou, Guangdong, 515041, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Changsha, Hunan, 410008, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, 210000, China
Local Institution
Nanjing, Jiangsu, 210002, China
Local Institution
Changchun, Jilin, 130012, China
Local Institution
Changchun, Jilin, 130021, China
Local Institution
Xi'an, Shan3xi, 710038, China
Local Institution
Xi'an, Shan3xi, 710061, China
Local Institution
Shanghai, Shanghai Municipality, 200025, China
Local Institution
Shanghai, Shanghai Municipality, 200032, China
Local Institution
Chengdu, Sichuan, 610041, China
Local Institution
Hangzhou, Zhejiang, 310003, China
Local Institution
Hangzhou, Zhejiang, 310009, China
Local Institution
Hangzhou, Zhejiang, 310016, China
Local Institution
Hangzhou, Zhejiang, 310022, China
Local Institution
Beijing, 100071, China
Local Institution
Chongqing, 400038, China
Local Institution
Fuzhou, China
Local Institution
Kunming, China
Local Institution
Shanghai, 200030, China
Local Institution
Berlin, 13125, Germany
Local Institution
Halle, 06120, Germany
Local Institution
Hamburg, 21075, Germany
Local Institution
Leipzig, 04357, Germany
Local Institution
Löwenstein, 74245, Germany
Local Institution
Mainz, 55131, Germany
Pulmonologiai Klinika
Budapest, 1125, Hungary
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
Deszk, 6772, Hungary
Torokbalinti Tudogyogyintezet
Törökbálint, 2045, Hungary
Oddzial Onkologiczny
Elblag, 82-300, Poland
Oddzial Chemioterapii
Poznan, 60-569, Poland
Klinika Nowotworow Pluca i Klatki Piersiowej
Warsaw, 02-781, Poland
Local Institution
Singapore, 169610, Singapore
Local Institution
Singapore, 308433, Singapore
Local Institution
Cheongju-si, Chungcheonbuk-do, 28644, South Korea
Local Institution
Suwon, Gyeonggi-do, 16499, South Korea
Local Institution
Hwasun-gun, Jeollanam-do, 58128, South Korea
Local Institution
Seoul, 03722, South Korea
Local Institution
Seoul, 05368, South Korea
Local Institution
Seoul, 06351, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 31, 2014
Study Start
October 13, 2014
Primary Completion
May 3, 2018
Study Completion
May 3, 2018
Last Updated
August 28, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-07